Posted
by
timothy
on Friday December 06, 2013 @08:55PM
from the regulators-know-best dept.

sciencehabit writes "The company 23andMe will no longer provide health information to people who purchase its DNA testing kit, it announced last night.The change was 'to comply with the U.S. Food and Drug Administration's directive to discontinue new consumer access during our regulatory review process,' the statement said. While current customers will still have access to a 23andMe online database noting the health issues associated with their particular DNA, the company will not update that information, and customers who purchased its Personal Genome Service (PGS) on or after 22 November will receive only information about their ancestry and their raw genetic data without interpretation." It would be great to see a secondary market in this kind of analysis emerge.

The easiest way to make a report is to visit promethease.com. This takes about 10 minutes and costs $5. [...] Promethease is a tool to build a personal DNA report based on SNPedia and a person's genotype (DNA) data. Customers of DNA testing services (23andMe, FamilyTreeDNA, Ancestry.com, Complete Genomics,...) can use it to learn more about themselves completely independently of whichever company produced their data.

A "secondary market" for running thousands of tests at once would run into the same problem that 23andMe did: if you are going to sell diagnostic services in the USA then you will need to get FDA approval. The options are to only provide raw data and let someone else generate the report for free (see Promethease, mentioned below) or move the whole company someplace where law enforcement won't bother it. I could see 23andMe spinning off an independent foundation that would generate free reports, thus allowing their core business (building up a database of peoples DNA and personal/family medical histories that they can rent out for medical research free from the normal regulatory hurdles) to proceed unhindered. They would just have to be very careful to make certain there was no linkage between the for profit and the free companies: the non-profit would have to generate reports from data of any source, not just SNPs from 23andMe, it couldn't share any board members or employees with 23andMe, Google, etc.

Next legal challenge for 23andMe: doing medical research on people (gathering their DNA and medical histories, analyzing, allowing 3rd parties to analyze, etc) without getting IRB approvals first.

One company, for example, offers 166 tests in one of its testing packages where approximately 60% of the tests (99) are categorized as âpreliminary researchâ(TM) because the genetic-association data have not yet been replicated (www.23andme.com/health/all/). These tests are given 1, 2, or 3 stars based on the size of the study that supports the genetic association for which they test. Information for each of these tests cites references for the original ïnding of the genetic association, including the journal where it was published and the study size. It also provides the number of attempted replications and the number of contrary studies that have been published. Although transparent, examination of the scientiïc evidence provided for many of the genetic associations in this category raises the question of whether these tests should even be included in a genetic-testing package. Two of the ïve genetic tests with 1-star status (those for âavoidance of errorâ(TM) and âobsessive compulsive disorderâ(TM)) are based on single studies with fewer than 100 participants (https://www.23andme.com/you/health/). In both cases the variants map to the D2 dopamine receptor, a gene that has repeatedly been associated with human behavioral traits and attracted newspaper headlines, only to have the associations refuted in later studies [8]. Eight of the 37 (22%) available 2-star-rated genetic associations (originating from a single study with less than 750 participants) have a âcontrary studyâ(TM) indicated. Two different 3-star tests, one for Lou Gehrigâ(TM)s Disease (ALS) and another for obesity, utilize variants that have been positively associated with disease in one or two studies, respectively. However, both these variants have failed replication in four additional studies (https://www.23andme.com/you/health/). Although, the company boasts of its 'systematic vetting processâ(TM) used to determine which research ïndings to include in its genetic-testing package, a number of highly questionable tests continue to be offered to consumers.

What 23andMe does is market a product that you use to extract unique information about your own body, which is then presented to you in the form of suggestions about what health measures you should take -- in other words, medical advice. Very different.

Whoa, what? They have never been in the business of medical advice! What they did is to say, "you have genetic marker X which according to studies A and B are indicative of a 20% increased susceptibility to disease Y or and 50% increased likelihood to have an adverse reaction to drug Z." That is not medical advice! That is mere information, filtered by your genetic markers.

The majority of the really useful information is genetic. The health information was secondary. Really, the whole health thing was vague at best, and it didn't take a rocket scientist to figure it out.

For example, gallstones. My risk is 6.2%, where avg risk is 7.0%. Not bad, I have a lower chance.

I had to have my gallbladder removed a year ago, because I had two golf ball size stones. Yup, anything greater than a 0.0% chance means there is a chance. Lucky me.

Anyways, here's the full email they just sent out to 23andMe customers today.

Dear 23andMe Customers,

I'm writing to update you on our conversation with the U.S. Food and Drug Administration and how it impacts you.

If you are a customer whose kit was purchased before November 22, 2013, your 23andMe experience will not change. You will be able to access both ancestry and health-related information as you always have.

23andMe has complied with the FDA's directive and stopped offering new consumers access to health-related genetic results while the company moves forward with the agency's regulatory review processes. Be sure to refer to our 23andMe blog for updates.

We stand behind the data we have generated for customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 - known as CLIA. These are the same standards used in the majority of other health and disease-related tests.

You are among the first people in the world to ever get access to their genomes. You are genetic pioneers. Thank you for your ongoing support and we look forward to continuing to serve you.